29 November - 1 December 2023
Heidelberg, Germany
A new Warning Letter has been issued by the U.S. Food and Drug Administration (FDA) and published on their website on August 1, 2023. The document, dated July 28, 2023, pertains to an inspection from November 22 to December 2, 2022, at a drug manufacturing facility in Sanand (Gujarat, India). The company under scrutiny is a drug manufacturer.
The letter addresses various concerns regarding data, quality and the absence of crucial laboratory control procedures.
The Warning Letter specifically notes a computer-related breach that concerns QC oversight:
"Your firm's quality control unit failed to exercise its responsibility to ensure drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). You should have ensured data reliability regarding the quality of medicines produced at your facility. Our inspection revealed serious deviations, including but not limited to inadequate oversight of original CGMP documents, deficient controls over computerized systems, insufficient laboratory investigations, and aborted chromatographic sequences."
Observation 10 in the associated US FDA Form 483, dated December 2022, highlights computer-related violations above.
Appropriate controls are not exercised over computers or related systems to ensure that changes in master production and control records or other records are instituted only by authorized personnel.
In addition to the typical data integrity-related remediation and information to the FDA, it was asked to provide the following information:
A comprehensive assessment and remediation plan ensures that your QA department has the authority and resources to function effectively. The assessment should also include, but not be limited to:
The FDA concludes that the "quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture." The FDA recommends engaging a consultant based on the nature of the GMP violations.
It's crucial to comprehend that to establish and sustain GMP adherence systems, validation experts must acknowledge the regulatory authorities' expectations regarding the system's lifecycle, maintenance, and operations. These expectations are outlined in software development standards, as well as regulatory requirements and guidelines.
Author: Orlando Lopez